PMA P990037S026

Device: VASCULAR SOLUTIONS DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S026
Product code: MGB
Decision date: 2008-08-07
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: CHANGE IN THE QUALITY CONTROL DEVICE USED TO MONITOR THE STERILIZATION PROCESS, AND A CHANGE IN THE MATERIALS USED IN ONE ACCESSORY COMPONENT (SMALL BORE APPLICATOR TIP).

Current openFDA PMA Record#

Device: VASCULAR SOLUTIONS DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S026
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2008-08-07
Decision code: OK30
Date received: 2008-07-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE QUALITY CONTROL DEVICE USED TO MONITOR THE STERILIZATION PROCESS, AND A CHANGE IN THE MATERIALS USED IN ONE ACCESSORY COMPONENT (SMALL BORE APPLICATOR TIP).